STELLAR
Sotatercept for the Treatment of Pulmonary Arterial Hypertension
Patient / Population Intervention / Exposure Comparison Outcome
In 323 patients with pulmonary arterial hypertension, sotatercept added to background therapy improved 6-minute walk distance compared with placebo.
N
323
Design
Double-blind RCT
Endpoint
Change in 6-minute walk distance at 24 weeks
Relevance
2
Result+40.8 m placebo-corrected; clinical worsening or death HR 0.16.
Hoeper MM, et al. N Engl J Med. 2023;388(16):1478-1490. 10.1056/NEJMoa2213558
Discussion & critique
An activin-signalling inhibitor — a mechanism beyond vasodilators. Led to approval; ZENITH later showed a mortality-relevant benefit in high-risk PAH.